Pharmaceutical and biotechnological medicines are designed to cure, prevent or treat diseases; however, there are also risks particularly adverse drug reactions (ADRs) that can cause serious harm to patients. ADRs are common, frequently preventable cause of illness, disability and death. An ADR may be defined as “an appreciably harmful or unpleasant reaction, resulting from an intervention related to the use of a medicinal product, which predicts hazard from future administration and warrants prevention or specific treatment, or alteration of the dosage regimen or withdrawal of the product”.

Thus, for safety of medication, ADR monitoring is required for each medicine throughout its life cycle i.e. during development of drug such as pre-marketing including early stages of drug design, clinical trials and post-marketing surveillance. Pharmacovigilance (PV) plays a key role in the healthcare system through assessment, monitoring and discovery of interactions amongst drugs and their effects in human.

The adverse events reported by PV system will potentially benefit to the community due to their proximity to both the population and public health practitioners.

Therefore, with a goal to ensure benefits of use of medicine and to safeguard the health of the Indian population, we have decided to monitor ADRs in Indian population. All the regions across the country (India) where Medley Pharmaceuticals Pvt. Ltd. markets its medicines are involved in reporting ADR in the prescribed form (ADR form).

REPORTING OF ADR

If you are a healthcare professional/consumer and wish to report an adverse event which has occurred by treating patient /using any of our products, you can opt any of the following procedure to report an adverse event:

Download Adverse Event Reporting Form and send via any of the below mentioned method of communication,

Fill available information, Scan and e-mail the completed form to pv@medleylab.com